Major Responsibilities and Duties:

• Maintain a current understanding of pharmacology and toxicology literature and methodology. Get understanding of the latest status of competitors in the market to guide target product development.
• Design and manage non-clinical studies (GLP and non-GLP) for inclusion in regulatory submissions following regulatory requirements, including pharmacology, pharmacokinetics and toxicology.
• Work closely with the discovery group for therapeutic candidate selection.
• Collaborate with CMC team to ensure coordination of manufacturing activities and support for toxicology and pharmacology studies with compliance with regulatory requirements.
• Ensure bioanalytical and immunogenicity analysis method development/validation in collaboration with in-house and external bioanalytic professionals, and facility smooth technical transfer from non-clinical to clinical developments.
• Oversees CROs in the design, conduct, analysis and interpretation of pharmacology and toxicology studies, and conduct on-site inspection for documentation and data retention to ensure that studies are delivered within agreed quality, cost and timeline parameters.
• Review non-clinical study reports to ensure accurate reflection of study data and scientific interpretation of study results.
• Prepare and edit non-clinical documents for regulatory submission.
• Write position papers on safety, pharmacology and mode of action to support product development.
• The incumbent will report directly to the Head of Non-Clinical Development.
• Other work for request.

Qualifications:

• 
  M.S. or Ph.D. in Medicine, Biological Sciences, Toxicology, Pharmacology.
• Minimum 3 years working experience in non-clinical drug development area.
• Proven experience in design, coordination, analysis and documentation of non-clinical studies Independently.
• Ability to synthesize and interpret diverse, multidisciplinary data sets.
• Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in scientific writing.
• The ability to work independently and to collaborate with a multi-disciplined group in a goal- and team- oriented setting is required.
• Highly flexible, results oriented, independent self-starter and team player who enjoys working in a fast-paced dynamic environment.